Providing consulting, auditing and training services and products to various clients in the academic, biopharmaceutical, device and training industries. Recently supported the inspection readiness activities of a West-coast pharmaceutical company that led to a successful FDA Inspection and product approval; conducted quality systems management audits for a major East-coast Pharmaceutical company. Provided full audit reports along with recommendations for process improvements. Wrote SOPs/policies

Responsible for Clinical Quality Assurance / GCP leadership and strategy for Phase I – IV clinical trial programs for the company. Conducts US and ex-US audits of clinical investigator sites as well as vendors, contract research organizations, clinical databases and Clinical Study Reports. Ensures clinical trial GCP compliance oversight through regular reviews and assessments of clinical trial protocols, plans and strategies as well as all deliverables to be submitted to or reviewed by the FDA.

Conducted risk assessment analyses and investigations for training compliance. Managed and successfully closed the largest global CAPA for our organization regarding master training plans for employees. Served as training subject matter expert and provided training data to auditors during 30 internal audits and regulatory inspections. Designed and implemented over 13 electronic customer request forms to create, modify and maintain online training records and data for internal customers.

Responsible for the strategic implementation of audits, assessments, training and regulatory guidance for the organization as well as for the sponsor and client projects. Scheduled, planned and conducted audits of clinical investigator sites, clinical databases, clinical study reports, internal systems and vendors in an effort to ensure the highest level of regulatory compliance and inspection readiness. Responsible for Regulatory and Training activities for the organization.